Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • A 3D computational fluid dynamics (CFD) simulation result showing a scalar field contour in a branched tube system, with values ranging from 0.000 (blue) to 0.500 (red). The contour visualization highlights flow variation along the geometry, with red and orange indicating high scalar values in upper segments and blue-green regions representing lower values in the lower tube segments.

    How Shear Stress and Residence Time Simulations Shape Safer Biological Fluid Handling Devices

    The impact of shear stress is critical to effectively design medical devices that handle biological fluids such as proteins or cell culture media. For example, non-physiological shear stress (NPSS) on blood is a key factor because hemolysis (cell rupture) could occur due to accumulated stress.

  • Medical device simulation - Scientist interacting with holographic brain interface unlocking future insights focused bright glow

    How Computational Modeling and Simulation Accelerates Medical Device Innovation

    The costs of early-stage medical device development in North America and Europe continue to rise. Increasing technical complexity and the compounding costs of nonclinical and clinical evaluations are driving this trend.

  • Detailed 3D rendering of human facial muscles. A visual guide to the complex anatomy of the face and neck.

    Tissue Simulation: Advances for Next-Gen Medical Devices

    Today, 85% of the top 50 healthcare companies use Computational Modeling and Simulation (CM&S) to develop their products and processes. Whether it’s refining overall device parameters or optimizing critical requirements, engineering simulations help reduce development timelines and enhance design exploration.

  • A glowing 3D holographic display of a joint replacement procedure, showing the integration of an orthopedic implant with surrounding bone structures, surrounded by recovery data and mobility improvement charts.

    Regulatory Clearance through Computational Simulation: Industry Opinion, FDA Strategy, & Successful Case Studies

    Computational Modeling and Simulation (CM&S) for medical devices has become a pivotal tool across the medical device industry, complementing and often enhancing traditional bench testing and clinical studies.

  • FDA use of AI in medical device review - A computer chip labeled "AI" on the left side is connected by a black arrow pointing to the right, where wooden blocks stacked vertically spell out "FDA." Above the image is a bold caption that says "They're doing it!" in white text on a black background. The image suggests the FDA is adopting AI technology.

    How the FDA Is Using AI in Regulatory Review

    Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.

  • Purple text reads 'FDA rejects Lab Results?' next to a rubber stamp marked 'REJECTED' resting on a document.

    When FDA Trust Is Broken: Lessons from the MedLink Scandal

    In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

  • White and colored label rolls isolated on white background with shadow reflection. Color reels of labels for printers. Labels for direct thermal or thermal transfer printing. Abstract background.

    Medical Device Labeling Requirements: Compliance and Best Practices

    We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

  • Room for sterilization of medical instruments in a modern outpatient clinic

    Medical Device Sterilization Methods and EtO

    Sterilization is a critical process in the medical device industry as it provides a reliable way to ensure that devices are free from harmful microorganisms when they are used on patients. This blog talks about the categories of sterilization currently used on medical devices in manufacturing settings. It also addresses concerns surrounding the use of ethylene oxide (EtO), an indispensable method for sterilizing heat and moisture sensitive devices.

  • Mammalogist doctor examines a woman breasts and lymph nodes during appointment. Skillful oncologist puncture of mammary glands of young patient under review ultrasound for diagnosis of breast cancer.

    Considerations for Including Tissue Biopsies in Clinical Trials

    The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025. It provides recommendations for sponsors, investigators, institutions, and Institutional Review Boards (IRBs) on the safe and ethical incorporation of tissue biopsies in clinical trials.